Dr. Mona Al Sheikh
Research Question
Components of RQ
Formulating a RQ
How to develop RQ? Video
Types of RQs
Examples of Good and Flawed RQs
Research question is like a mission
statement. It determines many
actions that follow like the design,
the subjects, the indicator to be
measured and even the statistical or
qualitative analysis to be used.
Definition of Research Question
Components of a Research Question
Participants/Population/Problem
● Age
● Gender
● Ethnicity
● Nationality
● Education level
● Social status
● Socioeconomic level
● Family disease history
Intervention/exposure
● Drug/chemical/herb
● Physical activity
● Food intake/fasting
● Electric stimulation/thermal/vibration
● Instruction modality
● Behavior modification
● Exposure to sunlight/radiation/sounds
● Sleep deprivation
● TENS/Acupuncture
Comparison/alternative
● Tranditional curriculum
● Another classic treatment
● Different instructional strategy/assessment tool
● No intervention
● Placebo
● Prognostic factor
● Absence of risk factor
Outcome
● BMI
● Memory and retention/learning/Performance
● Pain threshold
● Sleep quality
● Addictive behavior
● Bone density
● Headache/migraine/seizure
● Mood
Study
● Qualitative
● Quantitative
● Correlation
● RCT
● Multivariate analysis
Characteristics of a good RQ
● Clear and focused. In other words, the question should clearly state what the
researcher needs to do.
● Not too broad and not too narrow. The question should have an
appropriate scope. If the question is too broad it will not be possible to answer it
thoroughly within the word limit. If it is too narrow you will not have enough to
write about and you will struggle to develop a strong argument (see the activity
below for examples).
● Not too easy to answer. For example, the question should require more than
a simple yes or no answer.
● Not too difficult to answer. You must be able to answer the question
thoroughly within the given timeframe and word limit.
● Researchable. You must have access to a suitable amount of quality research
materials, such as academic books and refereed journal articles.
● Analytical rather than descriptive. In other words, your research question
should allow you to produce an analysis of an issue or problem rather than a
simple description of it (more on this below).
Consider the following when
developing a research question
Is it an open-ended question?
Is it appropriate in scope? Focused and narrow enough
Does it suggest factors that can be measured?
Is it relevant to my audience?
Is answering the question manageable?
Is the topic of interest to me?
Description of a Random Controlled Trial
● CONSORT 2010 : guideline intended to improve the
reporting of randomized controlled trials.
● SPIRIT 2013 : evidence based recommendations for the
minimum content of a controlled trial.
● TIDieR 2014 checklist: template for intervention description
and replication.
Formulating a Research Question
Activity I
Narrowing down your topic
● Create three columns on a piece of paper, in a word document, or
in a spreadsheet.
● Select a broad topic for an upcoming assignment or choose a topic
that you are interested in.
● In the first column write down the items contained in the first
column below. Add any other items that may be relevant to your
topic.
● In the second column write down potential sub-topics and other
limitations.
● In the third column write the potential value of what you have
written in the second column. What would that sub-topic or other
limitation allow you to prove or demonstrate?
● Circle or highlight the items in column two that have the strongest
potential value.
Activity I
Narrowing down your topic
● Create three columns on a piece of paper, in a word document, or
in a spreadsheet.
● Select a broad topic for an upcoming assignment or choose a topic
that you are interested in.
● In the first column write down the items contained in the first
column below. Add any other items that may be relevant to your
topic.
● In the second column write down potential sub-topics and other
limitations.
● In the third column write the potential value of what you have
written in the second column. What would that sub-topic or other
limitation allow you to prove or demonstrate?
● Circle or highlight the items in column two that have the strongest
potential value.
Breast Cancer Early Detection
Self Examination
Mammogram
Surgical Resection
Early Treatment
Better outcome
Prevent metastasis
Prevent mortality
Breast Cancer
Etiology
Genetic
Iatrogenic
Environmental
Prevention of BC
Genetic Engineering
Prevalence <5%
Activity II
Fine Tuning RQ
● What are the effects of using social media
in the online classroom?
● How does “Telegram” impact
synchronized online learning in UG
medical students ?
Activity II
Fine Tuning RQ
● ‘Is starting aspirin at 12 weeks of gestation
in women at risk of pre-eclampsia a useful
treatment?’
● Does starting aspirin in women at risk of
pre-eclampsia at 12 weeks of gestation
reduce the risk of preterm delivery when
compared with usual care?’
https://youtu.be/71-GucBaM8U
https://youtu.be/LWLYCYeCFak
Types of Research Questions
Descriptive
Comparative
Causal
Types of Research Questions
Types of Research Questions
Descriptive Research Question
A question for a study that aims to describe something
Examples:
• How many calories do Saudis consumer per day?
• What are the important factors that determine admission to
medical schools in the Kingdom?
• What proportion of Saudi students get accepted in top
American and Canadian universities?
Comparative Research Question
Comparative RQ focusses on comparison of the dependent variable
between two or more groups
Examples:
• What is the difference in average BMI between Saudi men and
women ?
• What is the difference perception of the Educational Environement
between traditional and PBL students?
• Which is more reliable in assessment of second year medical
students, multiple choice or extended matching items?
Causative Research Question
Describes a study that tries to find if one variable causes another
Example:
• What is the relationship between Educational Environement
measurement and educational strategy?
• What is the relationship between gender and BMI in Saudi Arabia?
• What is the relationship between contraceptive pill use and breast
cancer?
Examples
● Does medication help
alleviate attention deficit
hyperactivity disorder
(ADHD) symptoms? And
do kids need more exercise?
● How effective are the
various types of medication
in treating elementary
students with ADHD?
● How do artificial
sweeteners affect people?
● How does aspartame affect
post-menopausal women
who suffer from migraines?
Summary
● PICOS
● Formulating a RQ: Broad idea, general RQ, refine RQ, final
tune RQ.
● Types of RQs: Descriptive, comparative, and analytic.
● Common mistakes: Too broad, indicator is not measurable,
outcome is vague, study design does not match.
● Tips:
Ø READ
Ø READ
Ø READ
References
● Lane S. A good study starts with a clearly defined question:
Research question 1 of 2: how to pose a good research
question. BJOG : an international journal of obstetrics and
gynaecology. 2018;125(9):1057-
● Sandberg J, Alvesson M. Ways of constructing research
questions: gap-spotting or problematization? Organization
(London, England). 2011;18(1):23-44.
● Lane S. The best evidence comes from the right study design,
not just randomised trials: Research question 2 of 2: the
importance of research design. BJOG : an international
journal of obstetrics and gynaecology. 2018;125(12):1504-.
References
● Hoffmann, T.C., Glasziou, P.P., Boutron, I., Milne, R., Perera,
R., Moher, D., Altman, D.G., Barbour, V., Macdonald, H.,
Johnston, M., Lamb, S.E., Dixon-Woods, M., McCulloch, P.,
Wyatt, J.C., Chan, A. & Michie, S. 2014, "Better reporting of
interventions: template for intervention description and
replication (TIDieR) checklist and guide", BMJ: British
Medical Journal, vol. 348, no. mar07 3, pp. g1687-g1687.
● Kamper, S.J. 2018, "Asking a Question: Linking Evidence
With Practice", The journal of orthopaedic and sports
physical therapy, vol. 48, no. 7, pp. 596-597.
● Lane, S. 2018, "A good study starts with a clearly defined
question: Research question 1 of 2: how to pose a good
research question", BJOG : an international journal of
obstetrics and gynaecology, vol. 125, no. 9, pp. 1057-1057.
Dr. Mona Al Sheikh
Research Design
Objectives
● Research definition
● Research purpose
● How to do research?
● General types of research
● Qualitative vs quantitative design
● Observational vs experimental design
● Types and hierarchy of quantitative design
● Importance of design
● Design report
● Observational study design
What is Research?
Research is any original and systematic
investigation undertaken in order to increase
knowledge, understanding, to establish facts
and principles. It comprises the creation of
ideas and generation of knowledge that lead to
new and substantial improved insights and/or
the development of new materials, devices,
products and processes.
Purpose of Research
● Finding answers to questions or solutions to problems
● Discovering new facts
● Testing theories to revise accepted theories or laws in
light of new facts
● Planning and National development
How to do Research
● Research is all about addressing an issue or answering a
question or solving a problem
● Identify an issue, question, or problem.
●Talk with people who want or need your study.
● Find out what's already known about it.
●Talk with experts and/or read their reviews and the
original research on the topic.
● Plan, cost, and do your study accordingly.
● Write it up and submit it for assessment.
● Submit it for publication.
Types of Research
● Fundamental vs Applied
● Descriptive vs Analytical
● Quantitative vs Qualitative
● Conceptual vs Empirical
Fundamental and Applied research
● Fundamental or basic research seeks new knowledge about a
certain process . For example “ How does a panic attach
occur”? Or “How is long memory stored in the brain?”
● Applied research seeks solutions to an existing problem. For
example “What is the best management of a panic disorder”?
Or “ What encourages long term memory and retention”?
Descriptive vs Analytic
● Descriptive research classifies, describes, compares, and
measures data. For example “ How students perceive their
educational environment”? Or “ How do parents of autistic
children face the disability”? Or “ How do breast cancer
patients feel about their disease”?
● analytical research focuses on cause and effect. For example:
“ Why do parents of autistic children divorce”? “What are the
reasons behind low evaluation of students of their teachers”? Or
“ Why do breast cancer patients have insomnia”?
Quantitative vs Qualitative
● Quantitative research measures numbers of a certain
phenomenon. For example, “To what extent are students
satisfied with their educational environment”? Or “ What is
the recovery rate of breast cancer patients”?
● Qualitative research describes the phenomenon. For example,
“ What are the best and worst experiences students had
during their medical school”? Or “ How do breast cancer
patients perceive family members reaction to their illness”?
Conceptual vs Empirical
● Conceptual research involves abstract ideas and concepts and
the researcher uses the literature to explain a particular
phenomenon and is the basis of philosophical research. For
example, “ How do initial expectations of researcher
influence study results”?
● Empirical research involves research based on observation,
experiments and verifiable evidence. The conclusions of this
research are based on concrete evidence and observations.
For example, “ To what extent does taking iron supplements
prevent pregnancy anemia”?
Types of Empirical Research
Qualitative vs Quantitative Research
Quantitative
Methods
Observational
Experimental
Mixed
Sampling: Random
(simple, stratified, cluster,
etc) or purposive
Qualitative
Methods
Focus Groups
Interviews
Surveys
Self-reports
Observations
Document analysis
Sampling: Purposive
Research
Designs
Qualitative Quantitative
Experimental
Observational
Experimental
True
Experimental
Quasi
Experimental
RESEARCH METHODOLOGY
Descriptive Studies
Descriptive research is an observational / non – experimental
research design which is designed to discover new meanings and
to provide new knowledge where there is very little known about
the phenomena of interest.
It is designed to gather descriptive information and provides
information for formulating more sophisticated studies.
Description and explanation are its two aims.
Descriptive research aims at identifying the various
characteristics of a community or problem under study but it does
not deal with testing of hypothesis, in fact it leads to hypothesis
testing by exploring the problem.
Observational Research Designs
● Descriptive Design
● Case Study
● Case Series
● Cross – Sectional Designs
● Descriptive Cross – Sectional
● Analytical Cross – Sectional
● Correlational Design or Ecological Design
● Retrospective Design (Case – Control Study)
● Prospective Design (Cohort Study)
Case Study
A case study (case report) is a method of
descriptive research that documents a
practitioner’s experiences, thoughts, or
observations related to the care of a single client.
Case Series
A case series combines the observations from a
group of similar clients
Case Studies Usually Feature
● New disease or condition
● Rare or sparsely reported condition
● Unusual presentation of a common disease
● Impact of one disease process on another
● Unexpected event in the course of observing or
treating a patient
● Impact of a treatment regime of one condition on
another condition
● Unexpected complication of treatment or
procedure
● New and unique treatment
Cross-sectional studies
● Cross-Sectional Studies measure existing disease and
current exposure levels.
● They provide some indication of the relationship
between the disease and exposure or non-exposure.
● Sample at one point in time
● Mostly prevalence studies
Case-control studies
● Case-Control Studies identify existing disease/s and
look back in previous years to identify previous
exposures to causal factors.
● Cases are those who have a disease.
● Controls are those without a disease.
Activity I
Narrowing down your topic
Analytical Studies: Summary
Cost Cross
Sectional
Case Control Cohort RCT
Duration
Sample size
Incidence/
Prevalence
Multiple
Outcomes
Bias Prone
Causality
Analytical Studies: Summary
Activity III
Narrowing down your topic
Cross Sectional Study Design
Example of a Cross-Sectional Study
Association between garlic consumption and CAD
in the Family Practice Clinic
Cross-sectional Study
Sample of Population
Garlic Eaters Non-Garlic Eaters
Prevalence of
CAD
Prevalence of
CAD
Time Frame = Present
Cross-sectional Study
Garlic Consumption
+ -
C
A
D
+
- 90
10 90
10
Advantages
● Good design for hypothesis generation
● Can estimate overall and specific disease prevalence
and sometimes rates
● Can estimate exposure proportions in the population
● Can study multiple exposures
● Relatively easy, quick and inexpensive
● No issue of subjecting any animals or producers to
particular treatments
● Often good first step for new study issue
Disadvantages
● Impractical for rare diseases
● Not a useful type of study for establishing causal
relationships
● Confounding is difficult to control
● Recall of previous exposure may be faulty
Activity II
Narrowing down your topic
The Past The Present
Exposure
present
Exposure
present
Sample
of cases
Population
with disease
(cases)
Sample
of controls
Much larger
population
without
disease
(controls)
No
Outcome
Outcome
Exposure
absent
Exposure
absent
Case-Control Design
Example of a Case-Control Study
Oral Contraceptive use and breast Cancer?
Example of Case-Control Design: OC
Use and Breast Cancer
The Past or Present The Present
OC Use
OC Use
Sample
of cases
Population
with disease
(cases)
Sample
of controls
Much larger
population
without
disease
(controls)
No
Breast
Cancer
Breast
Cancer
OC Use
absent
OC Use
absent
Example of a Case-Control Study
CAD is less likely to those who consume garlic?
Case-Control Study
Patients with CAD
Patients w/o CAD
Present
Past
High Garlic Diet
High Garlic Diet
Low Garlic Diet
Low Garlic Diet
Cases
Controls
Case-Control Studies: Strengths
● Good for rare outcomes:
● Since the study begins with subjects who already have the outcome, it is
easier to accumulate enough subjects for significant results.
● Can examine many exposures
● Useful to generate hypothesis
● Fast
● Cheap
● Provides Odds Ratio
Case / Control Studies
Disadvantages
● Data Quality
● Data with inadequate detail, questionable reliability, or
use a different standard to judge disease severity.
● Recall bias
● Subjects who have unpleasant experiences may recall
past differently than control subjects.
● Cannot calculate prevalence or incidence and relative risk.
● Can only study one outcome
● Subject to confounding factors.
Correlational Research
Operational Definition:
A statistical analysis of covariant data to determine
a relationship. Researcher makes no attempt to
manipulate an independent variable.
Purpose:
This research technique is used to relate two or
more variables and allow predictions of
outcomes based on causative relationships
between the variables
Correlation and Significance
● Is there a relationship between two variables?
● What is the direction of the relationship?
● What is the magnitude?
● Pearson’s product moment coefficient correlation: -1.0
to +1.0
Correlation and Significance
A correlation refers to an association or a relationship between
two entities. A correlational research studies how one entity
impacts the other and what are the changes that are observed
when either one of them changes. This research method is
carried out to understand naturally occurring relationships
between variables.
The Process
● Participant and instrument selection
● Minimum of 30 subjects
● Instruments must be valid and reliable
● Higher validity and reliability requires smaller samples
● Lower validity and reliability requires larger samples
● Design and procedures
● Collect data on two or more variables for each subject
● Data analysis
● Compute the appropriate correlation coefficient
Research by Correlation
Figure 4.1 These three graphs represent hypothetical correlations between age and sleep problems.
Levels of correlation coefficient:
● 0.00 to 0.20 Negligible
● 0.20 to 0.40 Low
● 0.40 to 0.60 Moderate
● 0.60 to 0.80 Substantial
● 0.80 to 1.00 High to very high
Cohort Study
● Begin with disease-free patients
● Classify patients as exposed/unexposed
● Record outcomes in both groups
● Compare outcomes using relative risk
Cohort studies
● longitudinal
● Prospective studies
● Forward looking study
● Follow-up Study
● Incidence study
Activity III
Narrowing down your topic
Prospective Cohort
The Future
Outcome
Outcome
No Outcome
No Outcome
Prospective Cohort Design
The Present
Exposure present
Exposure absent
Sample
Population
The Future
Death
Death
No Death
No Death
Example of a Prospective Cohort Design:
Treatment of Severe Malaria in Children
The Present
Sample
PTX present
PTX absent
Population
General consideration while selection of cohorts
● Both the cohorts are free of the disease.
● Both the groups should equally susceptible to
disease
● Both the groups should be comparable
● Diagnostic and eligibility criteria for the disease
should be defined well in advance.
Example of a Cohort Study
To observe the effects of garlic use on CAD mortality in
a population?
Prospective Cohort Study
Garlic Free
Garlic
Eaters
No
CAD
CAD
CAD
No CAD
Present Future
Cohort studies
Strengths
● We can find out incidence rate
● More than one disease related to single exposure
● can establish cause - effect
● good when exposure is rare
● Eliminates recall bias
● minimizes selection and information bias
● Can calculate relative risk
Cohort Study: Weaknesses
● Expensive
● Time consuming
● Lost to follow-up
● Cannot study rare outcomes
● Confounding variables
● often requires large sample
● ineffective for rare diseases
What are RCTs?
● “A study where people are allocated randomly to
receiving a particular intervention or not (this
could be two different treatments or one
treatment and a placebo). This is the best type of
study design to determine whether a treatment
is effective.”
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RCT setup
Participants
Intervention Group (IG)
& Comparison Group (CG)
Outcome
I
G
CG
+ -
+
- D
C
B
A
Recruitment
VALIDITY
Maintenance
comparable groups?
treated equally?
compliant?
Measurements
blind
subjective? OR
objective?
QUESTION:
Allocation
concealment?
RAMMBO
www.cebm.net
Appraisal checklist - RAMMbo
Internal validity – minimising biases
Recruitment
• Who did the subjects represent?
Allocation
• Was the assignment to treatments randomised?
• Were the groups similar at the trial’s start?
Maintenance
• Were the groups treated equally?
• Were outcomes ascertained & analysed for most patients?
Measurements
• Were patients and clinicians “blinded” to treatment? OR
• Were measurements objective & standardised?
Study statistics (p-values & confidence intervals)
Guyatt. JAMA, 1993
www.cebm.net
Ensuring Allocation Concealment
BEST – most valid technique
Central computer randomization
DOUBTFUL
Envelopes, etc
NOT RANDOMIZED
Date of birth, alternate days, etc
www.cebm.net
Effects of non-equal treatment
Apart from actual intervention - groups should
receive identical care!
Trial of Vitamin E in pre-term infants (1948)
Vitamin E "prevented" retrolental fibroplasia
(By removal from 100% Oxygen to give the
frequent doses of Vitamin E!)
Rx: Give placebo in an identical regime, and a standard protocol
www.cebm.net
Intention-to-Treat Principle
Maintaining the randomization
Principle:
Once a patient is randomized, s/he should be
analyzed in the group randomized to - even if they
discontinue, never receive treatment, or crossover.
Exception: If patient is found on BLIND reassessment to
be ineligible based on pre-randomization criteria.
www.cebm.net
Measurement Bias
• Blinding – Who?
• Participants?
• Investigators?
• Outcome assessors?
• Analysts?
• Most important to use "blinded" outcome assessors
when outcome is not objective!
• Papers should report WHO was blinded and HOW it
was done
Schulz and Grimes. Lancet, 2002
www.cebm.net
Assessing the role of chance
• P-values (Hypothesis Testing)
• use statistical test to examine the ‘null’ hypothesis
• associated with “p values” - if p<0.05 then result is statistically
significant
• Confidence Intervals (Estimation)
• estimates a range of values that is likely to include the true
value
Clinical Question
In people who take long-haul flights
does wearing graduated compression
stockings prevent DVT?
Page 71 and 95 in your books
Participants
Intervention Group (IG)
& Comparison Group (CG)
Outcome
QUESTION:
VALIDITY
Summary
● Choose the best study design that matches the RQ
● Adhere to internal and external validity issues
● Cohort studies and RCT give the best evidence but are the
most time and money consuming
● Common mistakes: Conclude cause and effect
in a correlational study design.
● Tips:
Ø Weight strength of evidence with feasibility and time
Ø Teamwork
Ø Peer revision
References
msheikh@iau.edu.sa
Mona AlSheikh
@MonAlSheikh
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Contact

Research Question and Study Design

  • 1.
    Dr. Mona AlSheikh Research Question
  • 2.
    Components of RQ Formulatinga RQ How to develop RQ? Video Types of RQs Examples of Good and Flawed RQs
  • 3.
    Research question islike a mission statement. It determines many actions that follow like the design, the subjects, the indicator to be measured and even the statistical or qualitative analysis to be used. Definition of Research Question
  • 4.
    Components of aResearch Question
  • 5.
    Participants/Population/Problem ● Age ● Gender ●Ethnicity ● Nationality ● Education level ● Social status ● Socioeconomic level ● Family disease history
  • 6.
    Intervention/exposure ● Drug/chemical/herb ● Physicalactivity ● Food intake/fasting ● Electric stimulation/thermal/vibration ● Instruction modality ● Behavior modification ● Exposure to sunlight/radiation/sounds ● Sleep deprivation ● TENS/Acupuncture
  • 7.
    Comparison/alternative ● Tranditional curriculum ●Another classic treatment ● Different instructional strategy/assessment tool ● No intervention ● Placebo ● Prognostic factor ● Absence of risk factor
  • 8.
    Outcome ● BMI ● Memoryand retention/learning/Performance ● Pain threshold ● Sleep quality ● Addictive behavior ● Bone density ● Headache/migraine/seizure ● Mood
  • 9.
    Study ● Qualitative ● Quantitative ●Correlation ● RCT ● Multivariate analysis
  • 10.
    Characteristics of agood RQ ● Clear and focused. In other words, the question should clearly state what the researcher needs to do. ● Not too broad and not too narrow. The question should have an appropriate scope. If the question is too broad it will not be possible to answer it thoroughly within the word limit. If it is too narrow you will not have enough to write about and you will struggle to develop a strong argument (see the activity below for examples). ● Not too easy to answer. For example, the question should require more than a simple yes or no answer. ● Not too difficult to answer. You must be able to answer the question thoroughly within the given timeframe and word limit. ● Researchable. You must have access to a suitable amount of quality research materials, such as academic books and refereed journal articles. ● Analytical rather than descriptive. In other words, your research question should allow you to produce an analysis of an issue or problem rather than a simple description of it (more on this below).
  • 11.
    Consider the followingwhen developing a research question Is it an open-ended question? Is it appropriate in scope? Focused and narrow enough Does it suggest factors that can be measured? Is it relevant to my audience? Is answering the question manageable? Is the topic of interest to me?
  • 12.
    Description of aRandom Controlled Trial ● CONSORT 2010 : guideline intended to improve the reporting of randomized controlled trials. ● SPIRIT 2013 : evidence based recommendations for the minimum content of a controlled trial. ● TIDieR 2014 checklist: template for intervention description and replication.
  • 13.
  • 14.
    Activity I Narrowing downyour topic ● Create three columns on a piece of paper, in a word document, or in a spreadsheet. ● Select a broad topic for an upcoming assignment or choose a topic that you are interested in. ● In the first column write down the items contained in the first column below. Add any other items that may be relevant to your topic. ● In the second column write down potential sub-topics and other limitations. ● In the third column write the potential value of what you have written in the second column. What would that sub-topic or other limitation allow you to prove or demonstrate? ● Circle or highlight the items in column two that have the strongest potential value.
  • 15.
    Activity I Narrowing downyour topic ● Create three columns on a piece of paper, in a word document, or in a spreadsheet. ● Select a broad topic for an upcoming assignment or choose a topic that you are interested in. ● In the first column write down the items contained in the first column below. Add any other items that may be relevant to your topic. ● In the second column write down potential sub-topics and other limitations. ● In the third column write the potential value of what you have written in the second column. What would that sub-topic or other limitation allow you to prove or demonstrate? ● Circle or highlight the items in column two that have the strongest potential value.
  • 16.
    Breast Cancer EarlyDetection Self Examination Mammogram Surgical Resection Early Treatment Better outcome Prevent metastasis Prevent mortality Breast Cancer Etiology Genetic Iatrogenic Environmental Prevention of BC Genetic Engineering Prevalence <5%
  • 17.
    Activity II Fine TuningRQ ● What are the effects of using social media in the online classroom? ● How does “Telegram” impact synchronized online learning in UG medical students ?
  • 18.
    Activity II Fine TuningRQ ● ‘Is starting aspirin at 12 weeks of gestation in women at risk of pre-eclampsia a useful treatment?’ ● Does starting aspirin in women at risk of pre-eclampsia at 12 weeks of gestation reduce the risk of preterm delivery when compared with usual care?’
  • 20.
  • 21.
  • 22.
    Descriptive Comparative Causal Types of ResearchQuestions Types of Research Questions
  • 23.
    Descriptive Research Question Aquestion for a study that aims to describe something Examples: • How many calories do Saudis consumer per day? • What are the important factors that determine admission to medical schools in the Kingdom? • What proportion of Saudi students get accepted in top American and Canadian universities?
  • 24.
    Comparative Research Question ComparativeRQ focusses on comparison of the dependent variable between two or more groups Examples: • What is the difference in average BMI between Saudi men and women ? • What is the difference perception of the Educational Environement between traditional and PBL students? • Which is more reliable in assessment of second year medical students, multiple choice or extended matching items?
  • 25.
    Causative Research Question Describesa study that tries to find if one variable causes another Example: • What is the relationship between Educational Environement measurement and educational strategy? • What is the relationship between gender and BMI in Saudi Arabia? • What is the relationship between contraceptive pill use and breast cancer?
  • 26.
    Examples ● Does medicationhelp alleviate attention deficit hyperactivity disorder (ADHD) symptoms? And do kids need more exercise?
  • 27.
    ● How effectiveare the various types of medication in treating elementary students with ADHD?
  • 28.
    ● How doartificial sweeteners affect people?
  • 29.
    ● How doesaspartame affect post-menopausal women who suffer from migraines?
  • 30.
    Summary ● PICOS ● Formulatinga RQ: Broad idea, general RQ, refine RQ, final tune RQ. ● Types of RQs: Descriptive, comparative, and analytic. ● Common mistakes: Too broad, indicator is not measurable, outcome is vague, study design does not match. ● Tips: Ø READ Ø READ Ø READ
  • 31.
    References ● Lane S.A good study starts with a clearly defined question: Research question 1 of 2: how to pose a good research question. BJOG : an international journal of obstetrics and gynaecology. 2018;125(9):1057- ● Sandberg J, Alvesson M. Ways of constructing research questions: gap-spotting or problematization? Organization (London, England). 2011;18(1):23-44. ● Lane S. The best evidence comes from the right study design, not just randomised trials: Research question 2 of 2: the importance of research design. BJOG : an international journal of obstetrics and gynaecology. 2018;125(12):1504-.
  • 32.
    References ● Hoffmann, T.C.,Glasziou, P.P., Boutron, I., Milne, R., Perera, R., Moher, D., Altman, D.G., Barbour, V., Macdonald, H., Johnston, M., Lamb, S.E., Dixon-Woods, M., McCulloch, P., Wyatt, J.C., Chan, A. & Michie, S. 2014, "Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide", BMJ: British Medical Journal, vol. 348, no. mar07 3, pp. g1687-g1687. ● Kamper, S.J. 2018, "Asking a Question: Linking Evidence With Practice", The journal of orthopaedic and sports physical therapy, vol. 48, no. 7, pp. 596-597. ● Lane, S. 2018, "A good study starts with a clearly defined question: Research question 1 of 2: how to pose a good research question", BJOG : an international journal of obstetrics and gynaecology, vol. 125, no. 9, pp. 1057-1057.
  • 33.
    Dr. Mona AlSheikh Research Design
  • 35.
    Objectives ● Research definition ●Research purpose ● How to do research? ● General types of research ● Qualitative vs quantitative design ● Observational vs experimental design ● Types and hierarchy of quantitative design ● Importance of design ● Design report ● Observational study design
  • 36.
    What is Research? Researchis any original and systematic investigation undertaken in order to increase knowledge, understanding, to establish facts and principles. It comprises the creation of ideas and generation of knowledge that lead to new and substantial improved insights and/or the development of new materials, devices, products and processes.
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    Purpose of Research ●Finding answers to questions or solutions to problems ● Discovering new facts ● Testing theories to revise accepted theories or laws in light of new facts ● Planning and National development
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    How to doResearch ● Research is all about addressing an issue or answering a question or solving a problem ● Identify an issue, question, or problem. ●Talk with people who want or need your study. ● Find out what's already known about it. ●Talk with experts and/or read their reviews and the original research on the topic. ● Plan, cost, and do your study accordingly. ● Write it up and submit it for assessment. ● Submit it for publication.
  • 43.
    Types of Research ●Fundamental vs Applied ● Descriptive vs Analytical ● Quantitative vs Qualitative ● Conceptual vs Empirical
  • 44.
    Fundamental and Appliedresearch ● Fundamental or basic research seeks new knowledge about a certain process . For example “ How does a panic attach occur”? Or “How is long memory stored in the brain?” ● Applied research seeks solutions to an existing problem. For example “What is the best management of a panic disorder”? Or “ What encourages long term memory and retention”?
  • 45.
    Descriptive vs Analytic ●Descriptive research classifies, describes, compares, and measures data. For example “ How students perceive their educational environment”? Or “ How do parents of autistic children face the disability”? Or “ How do breast cancer patients feel about their disease”? ● analytical research focuses on cause and effect. For example: “ Why do parents of autistic children divorce”? “What are the reasons behind low evaluation of students of their teachers”? Or “ Why do breast cancer patients have insomnia”?
  • 46.
    Quantitative vs Qualitative ●Quantitative research measures numbers of a certain phenomenon. For example, “To what extent are students satisfied with their educational environment”? Or “ What is the recovery rate of breast cancer patients”? ● Qualitative research describes the phenomenon. For example, “ What are the best and worst experiences students had during their medical school”? Or “ How do breast cancer patients perceive family members reaction to their illness”?
  • 47.
    Conceptual vs Empirical ●Conceptual research involves abstract ideas and concepts and the researcher uses the literature to explain a particular phenomenon and is the basis of philosophical research. For example, “ How do initial expectations of researcher influence study results”? ● Empirical research involves research based on observation, experiments and verifiable evidence. The conclusions of this research are based on concrete evidence and observations. For example, “ To what extent does taking iron supplements prevent pregnancy anemia”?
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    Qualitative vs QuantitativeResearch Quantitative Methods Observational Experimental Mixed Sampling: Random (simple, stratified, cluster, etc) or purposive Qualitative Methods Focus Groups Interviews Surveys Self-reports Observations Document analysis Sampling: Purposive
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    Descriptive Studies Descriptive researchis an observational / non – experimental research design which is designed to discover new meanings and to provide new knowledge where there is very little known about the phenomena of interest. It is designed to gather descriptive information and provides information for formulating more sophisticated studies. Description and explanation are its two aims. Descriptive research aims at identifying the various characteristics of a community or problem under study but it does not deal with testing of hypothesis, in fact it leads to hypothesis testing by exploring the problem.
  • 56.
    Observational Research Designs ●Descriptive Design ● Case Study ● Case Series ● Cross – Sectional Designs ● Descriptive Cross – Sectional ● Analytical Cross – Sectional ● Correlational Design or Ecological Design ● Retrospective Design (Case – Control Study) ● Prospective Design (Cohort Study)
  • 57.
    Case Study A casestudy (case report) is a method of descriptive research that documents a practitioner’s experiences, thoughts, or observations related to the care of a single client. Case Series A case series combines the observations from a group of similar clients
  • 58.
    Case Studies UsuallyFeature ● New disease or condition ● Rare or sparsely reported condition ● Unusual presentation of a common disease ● Impact of one disease process on another ● Unexpected event in the course of observing or treating a patient ● Impact of a treatment regime of one condition on another condition ● Unexpected complication of treatment or procedure ● New and unique treatment
  • 60.
    Cross-sectional studies ● Cross-SectionalStudies measure existing disease and current exposure levels. ● They provide some indication of the relationship between the disease and exposure or non-exposure. ● Sample at one point in time ● Mostly prevalence studies
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    Case-control studies ● Case-ControlStudies identify existing disease/s and look back in previous years to identify previous exposures to causal factors. ● Cases are those who have a disease. ● Controls are those without a disease.
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    Analytical Studies: Summary CostCross Sectional Case Control Cohort RCT Duration Sample size Incidence/ Prevalence Multiple Outcomes Bias Prone Causality
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    Example of aCross-Sectional Study Association between garlic consumption and CAD in the Family Practice Clinic
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    Cross-sectional Study Sample ofPopulation Garlic Eaters Non-Garlic Eaters Prevalence of CAD Prevalence of CAD Time Frame = Present
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    Advantages ● Good designfor hypothesis generation ● Can estimate overall and specific disease prevalence and sometimes rates ● Can estimate exposure proportions in the population ● Can study multiple exposures ● Relatively easy, quick and inexpensive ● No issue of subjecting any animals or producers to particular treatments ● Often good first step for new study issue
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    Disadvantages ● Impractical forrare diseases ● Not a useful type of study for establishing causal relationships ● Confounding is difficult to control ● Recall of previous exposure may be faulty
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    The Past ThePresent Exposure present Exposure present Sample of cases Population with disease (cases) Sample of controls Much larger population without disease (controls) No Outcome Outcome Exposure absent Exposure absent Case-Control Design
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    Example of aCase-Control Study Oral Contraceptive use and breast Cancer?
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    Example of Case-ControlDesign: OC Use and Breast Cancer The Past or Present The Present OC Use OC Use Sample of cases Population with disease (cases) Sample of controls Much larger population without disease (controls) No Breast Cancer Breast Cancer OC Use absent OC Use absent
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    Example of aCase-Control Study CAD is less likely to those who consume garlic?
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    Case-Control Study Patients withCAD Patients w/o CAD Present Past High Garlic Diet High Garlic Diet Low Garlic Diet Low Garlic Diet Cases Controls
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    Case-Control Studies: Strengths ●Good for rare outcomes: ● Since the study begins with subjects who already have the outcome, it is easier to accumulate enough subjects for significant results. ● Can examine many exposures ● Useful to generate hypothesis ● Fast ● Cheap ● Provides Odds Ratio
  • 81.
    Case / ControlStudies Disadvantages ● Data Quality ● Data with inadequate detail, questionable reliability, or use a different standard to judge disease severity. ● Recall bias ● Subjects who have unpleasant experiences may recall past differently than control subjects. ● Cannot calculate prevalence or incidence and relative risk. ● Can only study one outcome ● Subject to confounding factors.
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    Correlational Research Operational Definition: Astatistical analysis of covariant data to determine a relationship. Researcher makes no attempt to manipulate an independent variable. Purpose: This research technique is used to relate two or more variables and allow predictions of outcomes based on causative relationships between the variables
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    Correlation and Significance ●Is there a relationship between two variables? ● What is the direction of the relationship? ● What is the magnitude? ● Pearson’s product moment coefficient correlation: -1.0 to +1.0
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    Correlation and Significance Acorrelation refers to an association or a relationship between two entities. A correlational research studies how one entity impacts the other and what are the changes that are observed when either one of them changes. This research method is carried out to understand naturally occurring relationships between variables.
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    The Process ● Participantand instrument selection ● Minimum of 30 subjects ● Instruments must be valid and reliable ● Higher validity and reliability requires smaller samples ● Lower validity and reliability requires larger samples ● Design and procedures ● Collect data on two or more variables for each subject ● Data analysis ● Compute the appropriate correlation coefficient
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    Research by Correlation Figure4.1 These three graphs represent hypothetical correlations between age and sleep problems.
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    Levels of correlationcoefficient: ● 0.00 to 0.20 Negligible ● 0.20 to 0.40 Low ● 0.40 to 0.60 Moderate ● 0.60 to 0.80 Substantial ● 0.80 to 1.00 High to very high
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    Cohort Study ● Beginwith disease-free patients ● Classify patients as exposed/unexposed ● Record outcomes in both groups ● Compare outcomes using relative risk
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    Cohort studies ● longitudinal ●Prospective studies ● Forward looking study ● Follow-up Study ● Incidence study
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    The Future Outcome Outcome No Outcome NoOutcome Prospective Cohort Design The Present Exposure present Exposure absent Sample Population
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    The Future Death Death No Death NoDeath Example of a Prospective Cohort Design: Treatment of Severe Malaria in Children The Present Sample PTX present PTX absent Population
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    General consideration whileselection of cohorts ● Both the cohorts are free of the disease. ● Both the groups should equally susceptible to disease ● Both the groups should be comparable ● Diagnostic and eligibility criteria for the disease should be defined well in advance.
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    Example of aCohort Study To observe the effects of garlic use on CAD mortality in a population?
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    Prospective Cohort Study GarlicFree Garlic Eaters No CAD CAD CAD No CAD Present Future
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    Cohort studies Strengths ● Wecan find out incidence rate ● More than one disease related to single exposure ● can establish cause - effect ● good when exposure is rare ● Eliminates recall bias ● minimizes selection and information bias ● Can calculate relative risk
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    Cohort Study: Weaknesses ●Expensive ● Time consuming ● Lost to follow-up ● Cannot study rare outcomes ● Confounding variables ● often requires large sample ● ineffective for rare diseases
  • 103.
    What are RCTs? ●“A study where people are allocated randomly to receiving a particular intervention or not (this could be two different treatments or one treatment and a placebo). This is the best type of study design to determine whether a treatment is effective.” www.nhs.uk/news/Pages/Newsglossary.aspx
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    Participants Intervention Group (IG) &Comparison Group (CG) Outcome I G CG + - + - D C B A Recruitment VALIDITY Maintenance comparable groups? treated equally? compliant? Measurements blind subjective? OR objective? QUESTION: Allocation concealment?
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    www.cebm.net Appraisal checklist -RAMMbo Internal validity – minimising biases Recruitment • Who did the subjects represent? Allocation • Was the assignment to treatments randomised? • Were the groups similar at the trial’s start? Maintenance • Were the groups treated equally? • Were outcomes ascertained & analysed for most patients? Measurements • Were patients and clinicians “blinded” to treatment? OR • Were measurements objective & standardised? Study statistics (p-values & confidence intervals) Guyatt. JAMA, 1993
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    www.cebm.net Ensuring Allocation Concealment BEST– most valid technique Central computer randomization DOUBTFUL Envelopes, etc NOT RANDOMIZED Date of birth, alternate days, etc
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    www.cebm.net Effects of non-equaltreatment Apart from actual intervention - groups should receive identical care! Trial of Vitamin E in pre-term infants (1948) Vitamin E "prevented" retrolental fibroplasia (By removal from 100% Oxygen to give the frequent doses of Vitamin E!) Rx: Give placebo in an identical regime, and a standard protocol
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    www.cebm.net Intention-to-Treat Principle Maintaining therandomization Principle: Once a patient is randomized, s/he should be analyzed in the group randomized to - even if they discontinue, never receive treatment, or crossover. Exception: If patient is found on BLIND reassessment to be ineligible based on pre-randomization criteria.
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    www.cebm.net Measurement Bias • Blinding– Who? • Participants? • Investigators? • Outcome assessors? • Analysts? • Most important to use "blinded" outcome assessors when outcome is not objective! • Papers should report WHO was blinded and HOW it was done Schulz and Grimes. Lancet, 2002
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    www.cebm.net Assessing the roleof chance • P-values (Hypothesis Testing) • use statistical test to examine the ‘null’ hypothesis • associated with “p values” - if p<0.05 then result is statistically significant • Confidence Intervals (Estimation) • estimates a range of values that is likely to include the true value
  • 114.
    Clinical Question In peoplewho take long-haul flights does wearing graduated compression stockings prevent DVT? Page 71 and 95 in your books
  • 115.
    Participants Intervention Group (IG) &Comparison Group (CG) Outcome QUESTION: VALIDITY
  • 117.
    Summary ● Choose thebest study design that matches the RQ ● Adhere to internal and external validity issues ● Cohort studies and RCT give the best evidence but are the most time and money consuming ● Common mistakes: Conclude cause and effect in a correlational study design. ● Tips: Ø Weight strength of evidence with feasibility and time Ø Teamwork Ø Peer revision
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